Federal Circuit Affirms Tygacil Formulation Patent

In a non-precedential decision in Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline were invalid as obvious. Both the PTAB and Federal Circuit decisions show that while the burden of proof is lower in an inter partes review proceeding than a district court proceeding, it still can be difficult to invalidate a patent. Indeed, Apotex’s second attempt to invalidate this Tygacil formulation patent in an inter partes review proceeding was denied institution in September 2015, while this appeal was pending. Continue reading this entry

USPTO Sued Over December 2015 Holidays

Elm 3DS Innovations, LLC has sued the USPTO in the U.S. District Court for the Eastern District of Virginia to challenge its authority to declare that December 22-24, 2015 were “holidays” because the USPTO had experienced a power outage that impacted its electronic filing systems. Elm asserts that it was harmed by this allegedly ultra vires action because it led the USPTO to accept petitions for Inter Partes Review of Elm patents after the statutory period of 35 USC § 315(b) had expired. If the USPTO’s authority to declare the holidays is not upheld, such a decision could have a far-reaching impact. Continue reading this entry

Construing Markush Group Claims

In Multilayer Stretch Cling Film v. Berry Plastics, the Federal Circuit provided a detailed discussion of the construction of claims that use Markush group language. The decision emphasizes the closed nature of the “consisting of” terminology, and underscores the care that should be used with Markush group claim language. Continue reading this entry

AbbVie Sues Amgen On 10 Of 100 Humira Patents

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA® infringes a number of AbbVie patents. The complaint specifically asserts infringement of ten HUMIRA® patents, but indicates that 51 others may be infringed. Did Congress strike the right balance when it gave biosimilar applicants the right to decide how many patents can be litigated in the first round of litigation under the BPCIA? Continue reading this entry

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination of patent applications directed to methods of treating cancer using immunotherapy. It will be interesting to see how many applicants take advantage of this program, and whether the program is effective to expedite grant of cancer immunotherapy patents.    Continue reading this entry